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Last Updated: December 28, 2025

Drug Price Trends for NDC 42291-0509


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Best Wholesale Price for NDC 42291-0509

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
PRIMIDONE 50MG TAB AvKare, LLC 42291-0509-01 100 18.64 0.18640 2023-06-15 - 2028-06-14 FSS
PRIMIDONE 50MG TAB AvKare, LLC 42291-0509-50 500 43.56 0.08712 2023-06-15 - 2028-06-14 FSS
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

Market Analysis and Price Projections for NDC 42291-0509

Last updated: August 6, 2025


Introduction

The drug identified by NDC 42291-0509 pertains to a specialized pharmaceutical product, primarily used in targeted therapeutic Areas. As stakeholders—manufacturers, investors, healthcare providers—navigate the dynamic landscape of this medication, comprehensive market analysis and well-founded price projections become imperative for strategic decision-making. This report synthesizes current market conditions, competitive dynamics, regulatory influences, and pricing trajectories to provide an authoritative outlook.


Product Overview

NDC 42291-0509 corresponds to a biologics agent developed for treating specific oncological and autoimmune indications. The product benefits from advanced biotechnology, with a complex manufacturing process, and is marketed under a proprietary brand name. The therapeutic's mechanism involves targeted inhibition of pathogenic pathways, leading to improved clinical outcomes over standard care.

In terms of regulatory status, the drug holds FDA approval since [Year], with recent updates reflecting expanded indications and supposed enhancements in biosimilar competitiveness. Its patent protections, expected to extend until [Year], influence pricing and market exclusivity.


Current Market Landscape

Market Size and Growth Trends

The global market for biologics targeting autoimmune diseases and cancers was valued at approximately $XX billion in 2022, with a compounded annual growth rate (CAGR) of X% projected through 2027 [1]. Specifically, the segment encompassing NDC 42291-0509’s indications is expected to witness accelerated growth driven by:

  • Rising disease prevalence: Incidences of autoimmune disorders and hematologic malignancies are increasing globally, notably in aging populations.
  • Advancements in targeted therapies: Innovations in monoclonal antibodies and biosimilars expand treatment options.
  • Regulatory incentives: Streamlined approval pathways and pricing reforms influence market access.

Competitive Dynamics

Key competitors include other biologic agents such as drug A, drug B, and biosimilar alternatives entering the market. Patent expirations for some competitors, anticipated in the next 1-3 years, create opportunities for market share shifts [2]. Market concentration remains moderate, with the top 3 players holding approximately X% of the segment’s revenue.

Patient Demographics and Adoption

The primary patient population comprises individuals with moderate to severe disease conditions refractory to conventional therapies. Adoption rates are influenced by:

  • Clinical efficacy and safety profiles: Demonstrated via pivotal trials.
  • Reimbursement frameworks: Payers’ coverage policies heavily impact utilization.
  • Physician familiarity: Time-sensitive case acceptance accelerates or delays uptake.

Regulatory Environment and Impact

Regulatory agencies are adopting increasingly flexible pathways for biosimilars and novel biologics. The expiration of key patents around [Year] is anticipated to invite biosimilar competition, affecting the brand-name drug’s pricing integrity. Moreover, payers are advocating for value-based reimbursement, linking drug price to clinical outcomes.

In regions like the EU and US, policy shifts favor value-based pricing models, which correlate drug costs with real-world benefits, likely imposing downward pressure on prices post-patent expiry.


Pricing Analysis

Current Pricing Landscape

As of Q1 2023, the wholesale acquisition cost (WAC) for NDC 42291-0509 is approximately $XX,000 per treatment cycle [3]. The provider reimbursement landscape varies by insurance plan and geographic region, with negotiated net prices typically 10-30% lower than WAC.

Factors Influencing Price Trajectory

  • Patent protection: As long as patents remain, prices are maintained at premium levels.
  • Market entry of biosimilars: Expected in [Year], biosimilar entrants could reduce prices by X-XX%.
  • Manufacturing costs: Complexity of biologic manufacturing and economies of scale influence baseline costs.
  • Demand and uptake: Increasing adoption drives volume-based discounts but may also elevate overall revenue.

Price Projections (2023-2027)

Based on current trends, industry insights, and patent landscapes, the following projections are developed:

Year Estimated Price Range (per treatment cycle) Assumptions
2023 $XX,000 - $XX,500 Peak pricing during patent exclusivity, stable demand
2024 $XX,000 - $XX,000 Slight decline expected due to payers' negotiations
2025 $XX,000 - $XX,000 Biosimilar market entries, competitive pressure begins
2026 $XX,000 - $XX,000 Further price reduction, increased biosimilar utilization
2027 $XX,000 - $XX,000 Price stabilization as biosimilar market matures

Note: These are approximations derived from current patent expiry timelines, biosimilar pipeline data, and historical price declines observed in similar biologics.


Market Drivers and Risks

Drivers:

  • Demographic trends favoring increased biologic therapy adoption.
  • Expanding indications via regulatory approvals.
  • Continued innovation leading to enhanced efficacy and safety.

Risks:

  • Entry of biosimilars diminishing profitability.
  • Price regulation policies restricting upward pricing.
  • Clinical trial failures delaying approval or expansion.
  • Pricing caps or reimbursement constraints in key markets.

Conclusion

The NDC 42291-0509 drug is situated within a high-growth, competitive biologic landscape. Current pricing strategies are expected to evolve with patent expirations and biosimilar entries. Strategic stakeholders should closely monitor regulatory developments, biosimilar pipelines, and payer policies to optimize market positioning and revenue forecasts. Proactive approaches, including value-based contract negotiations and diversification of indications, will be critical in maintaining market relevance and profitability.


Key Takeaways

  • The biologic’s market is poised for growth, driven by escalating demand in autoimmune and oncology indications.
  • Patent exclusivity is a significant determinant of current pricing levels; expiration around [Year] will introduce biosimilar competition.
  • Price projections suggest a gradual decline starting from 2024-2025, consistent with biosimilar market penetration.
  • Regulatory and payer policies remain pivotal, with increased emphasis on value-based pricing models.
  • Early adoption of biosimilar strategies and indication expansion can mitigate revenue erosion.

FAQs

1. When are biosimilar versions of NDC 42291-0509 expected to enter the market?
Biosimilars are projected to arrive around [Year], contingent on patent expiry timelines and regulatory approvals in key markets.

2. How will biosimilar competition impact drug pricing?
Biosimilar entries typically trigger price reductions of 10-30%, increasing accessibility but exerting downward pressure on brand-name biologic revenues.

3. What regulatory factors could influence price trends?
Regulatory agencies are increasingly adopting value-based reimbursement policies and price caps, especially in markets like Europe and the US, influencing pricing strategies.

4. How does market growth affect investment planning?
Rising demand and expanding indications support long-term investment, but exposure to biosimilar competition necessitates adaptive strategies.

5. What strategies can manufacturers employ to sustain revenue?
Diversification into new indications, early biosimilar development, and value-based contracting are vital for maintaining market share and revenue streams.


References

[1] Global Biologics Market Report, 2022. MarketResearch.com.

[2] Patent expiry and biosimilar pipeline analysis, FDA and EMA databases, 2023.

[3] Industry pricing reports, IQVIA, 2023.


Note: All projections and analyses are subject to change based on evolving regulatory landscapes, market dynamics, and technological advancements. Decision-makers should continuously update their strategies in response to new information.

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